Orthopedic, arthroscopic, spinal, and neurosurgical
For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.

Cutting
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.

Blended Cutting and Coagulation
Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.

Hemostasis and Nonablative Coagulation
Control of bleeding, Epilation, Telangiectasia

Bipolar
Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatop!asty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

Device Description

The SurgiMax / SurgiMax Plus is a compact source of high radiofrequency energy employed for a variety of procedures. This action is achieved by front panel selection of waveforms and power levels. The subject device can be used with monopolar or bipolar devices. The energy is used for cutting, coagulation, and hemostasis.

The SurgiMax / SurgiMax Plus Electrosurgery Generator is a compact source of high radio-frequency RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps, which give the operator feedback of status.

Power level for each mode is indicated by front panel digital displays; which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAIL is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered.

This device is designed to comply with international safety standards including applicable IEC series electrical safety standards.

The power output in the CW (Cut) mode is 120 watts into (500 ohms) a matched load. The output frequency is maintained at 4.0 MHz +/- 400Hz over all service and loading conditions including short and open for monopolar mode.

Three output waveforms are provided:

CW CUT - Continuous wave output with average power equal to the maximum with no deliberate modulation.

CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 75 Hz rate.

HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 75 Hz rate.

AI/ML Overview

The provided 510(k) summary for the Elliquence SurgiMax / SurgiMax Plus electrosurgical unit does not contain the information requested in your prompt regarding acceptance criteria and a detailed study proving performance.

This document is a marketing submission to the FDA demonstrating "substantial equivalence" to a predicate device, not a report of an original clinical or performance study with acceptance criteria.

Here's a breakdown of why the requested information is absent and what is provided:

1. A table of acceptance criteria and the reported device performance

Absent. The document does not define specific acceptance criteria for performance such as accuracy, sensitivity, or specificity, as it's not a diagnostic device. For an electrosurgical unit, performance is typically measured by output power, frequency, and waveform consistency. These specifications are provided in a table within the document (see "Output Characteristics:") but without explicit acceptance criteria or a formal performance study against them. Instead, it states the device "complies with IEC 60601-2-2."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Absent. No test set or associated data is described. The submission relies on "non-clinical testing and comparison between the subject device and predicate device" to demonstrate equivalent performance, which generally involves engineering bench testing rather than a clinical "test set" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Absent. Since there is no described test set involving patient data, there would be no ground truth established by medical experts for diagnostic purposes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Absent. No test set necessitating adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Absent. This device is an electrosurgical unit, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant and not part of this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Absent. Again, this is an electrosurgical unit, not an algorithm or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable/Absent. No "ground truth" for diagnostic purposes is relevant to this device. Performance is instead confirmed through engineering compliance and comparison to the predicate device's specifications.

8. The sample size for the training set

Not applicable/Absent. This is not an AI/machine learning device, so there is no training set mentioned.

9. How the ground truth for the training set was established

Not applicable/Absent. As above, no training set.

What the document does provide regarding performance and equivalence:

Predicate Device Comparison: The core of this 510(k) submission is to demonstrate "substantial equivalence" to a previously cleared device, the Ellman SurgiMax (K061174). The document explicitly states: "The subject device and predicate device have identical indications for use, waveforms, functionality with bipolar and monopolar devices, frequency, maximum power, weight, and power adjustment. The electronics and software in the subject device is the same identical electronics and software in the predicate device. The outputs and performance characteristics are identical as the electronics and software have not changed."
Compliance with Standards: It states that the "Ellman SurgiMax / SurgiMax Plus complies with IEC 60601-2-2." This international standard specifies general requirements for basic safety and essential performance of electrosurgical equipment. Compliance with such a standard serves as a key piece of performance evidence for this type of device.
Non-Clinical Testing: The document vaguely mentions "Non-clinical testing and comparison between the subject device and predicate device demonstrate equivalent performance." This typically refers to bench testing of electrical outputs, power delivery, safety features, etc., against the device's own specifications and the predicate's known performance, but no details of these tests (e.g., sample sizes, specific measurements, acceptance criteria) are provided in this summary.

In summary, for a device like an electrosurgical unit seeking 510(k) clearance, the "study" demonstrating it meets acceptance criteria often involves compliance with applicable recognized standards and benchtop engineering testing to prove that its specifications (like power output, frequency, and waveform) match those of a legally marketed predicate device, rather than a clinical study with patients and expert-adjudicated ground truth.

Summary

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K100390

510 (k) Summary

Date Prepared

AUG 2 5 2010

Revised August 19, 2010

Submitter's Information

Joseph Azary c/o Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Tel: (203) 922-0105 Fax: (203) 922-0130 Email: joseph.azary@orchid-orthopedics.com

Manufacturer/Sponsor: Elliquence LLC 3333 Royal Avenue Oceanside, NY 11572

Establishment Registration for Elliquence LLC Inc. is 3007024186.

Device Trade Or Proprietary Names

Possible device trade names are:

. SurgiMax
. SurgiMax Plus

Device Common, Usual, or Classification Names

Electrosurgical Unit and Accessories, Electrosurgical Cutting and Coagulation and Accessories

Classification Panel

Classification of this device would fall under the responsibility of the Division of General, Restorative, and Neurological Devices.

Class

Classification: Class 2 Product Code: GEI, 21 CFR 878.4400

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Description of the Device

This device is designed to comply with international safety standards including applicable IEC series electrical safety standards.

Three output waveforms are provided:

CW CUT - Continuous wave output with average power equal to the maximum with no deliberate modulation.

CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 75 Hz rate.

HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 75 Hz rate.

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Specifications:

Nominal Line Voltage:

240/220/120/100 V

Input Current at Max Output Power:

240/230/220V: 1.5A 120/100V: 3.3A

Width and Height:

।

9.25" x 5" x 13.25" (23.5cm x 1.7cm x 33.7cm)

Weight:

20 lbs (9.07 kg)

Output Characteristics:

Output Characteristics:
Mode	Output Wave-form	Max Power	Activation
CUT	4.0 MHz CWsinusoid	120 W at 500Ohms	Footswitch orfingerswitch
CUT/COAG	4.0 MHz withrectified fullwave envelope	90 W at 500Ohms	Footswitch orfingerswitch
HEMO	4.0 MHz withsquare waverectifiedenvelope	60 W at 500Ohms	Footswitch orfingerswitch
BIPOLARHEMO	1.7 MHz withsquare waverectifiedenvelope	40W at 200Ohms	Footswitch
BIPOLARTURBO	1.7 MHz withCW sinusoid	120W at 200Ohms	Footswitch

Intended Use [21 CFR 807.92(a)(5)]

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Orthopedic, arthroscopic, spinal, and neurosurgical

For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.

Cutting

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, turnors, cosmetic repairs, development of skin flaps, Blepharoplasty.

Blended Cutting and Coagulation

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.

Hemostasis and Nonablative Coagulation

Control of bleeding, Epilation, Telangiectasia

Bipolar

Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

Technological Characteristics [21 CFR 807.92(a)(6)]

Elliquence LLC believes that the subject device has the identical technological characteristics of the predicate device. This include outputs, performance, software, electronics, and indications for use. We believe the subject device is substantially equivalent to the predicate device.

Performance Data [21 CFR 807.92(b)(1)]

The Ellman SurgiMax / SurgiMax Plus complies with IEC 60601-2-2. Non-clinical testing and comparison between the subject device and predicate device demonstrate equivalent performance.

Predicate Device [21 CFR 807.92(a)(3)]

The predicate devices are listed as follows:

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Ellman Surgimax - K061174 .

The subject device and predicate device have identical indications for use, waveforms, functionality with bipolar and monopolar devices, frequency, maximum power, weight, and power adjustment. The electronics and software in the subject device is the same identical electronics and software in the predicate device. The outputs and performance characteristics are identical as the electronics and software have not changed.

The differences are:

. Cosmetic differences to the outer case and faceplate
. Difference in product name (Elliquence Surgimax or Elliquence Surgimax Plus versus Ellman Surgimax)
Labeling changed to reflect the company name and the image to reflect the cosmetic differences. .

These differences do not affect safety or performance as they are cosmetic or aesthetic in nature.

Conclusion [21 CFR 807.92(b)(3)]

We believe the differences between the subject device and predicate device are minor and conclude that the subject devices are as safe and effective as the predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Elliquence, LLC. % Orchid Design Mr. Joseph Azary 80 Shelton Technology Center Shelton, Connecticut 06484

AUG 2 5 2010

Re: K100390

Trade Name: Eliquence Surgimax / Surgimax Plus Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 20, 2010 Received: July 22, 2010

Dear Mr. Azary: .

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Joseph Azary

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm/15809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Coopliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffred number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/medicaldevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark M Millerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K100390

510(k) Number (if known):

Device Name: Elliquence Surgimax / Surgimax Plus

Indications For Use:

Orthopedic, arthroscopic, spinal, and neurosurgical

Cutting

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.

Blended Cutting and Coagulation

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.

Hemostasis and Nonablative Coagulation Control of bleeding, Epilation, Telangiectasia

Bipolar

Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatop!asty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

K100390

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.